PLYMOUTH MEETING, Penn. – Despite a clinical hold that delayed the beginning of a Phase III cancer trial, the past year has been one of positive growth for Inovio Pharmaceuticals (INO). After years of pioneering DNA-based vaccines and therapies targeting cancers and infectious diseases, the company is looking at 2021 for the launch of its first approved product.

“We’ve been very busy at Inovio,” Joseph Kim, president and chief executive officer of Inovio, told BioSpace in an exclusive interview.

Inovio has been focused on advancing its pipeline this past year. The company has one Phase III trial and four Phase II trials ongoing. Additionally, the company has several Phase I programs that could move into Phase II by 2018, Kim said.

Last year Kim toldBioSpace the company was anticipating its drug candidate VGX-3100 entering Phase III trials as a treatment for cervical dysplasia caused by the Human papillomavirus. VGX-3100 is a DNA-based immunotherapy under investigation for the treatment of HPV-16 and HPV-18 infection and pre-cancerous lesions of the cervix and vulva. However, in October 2016, the U.S. Food and Drug Administrationplaced a hold on its Phase III trial. That delay was something Kim said was expected as the company had developed a new delivery system for the drug. The company complied with the FDA’s request and earlier this month received the nod to begin the clinical trial.

“It’s not atypical to receive such a delay and now we’re looking forward to making up for that lost time,” Kim said.

The company is surging forward with 15 sites for the Phase III studies in order to meet its goal of having all data by 2020 in order to seek regulatory approval by 2021.

But it’s not just the movement on VGX-3100 that’s got Kim excited about the future. Since the start of 2017, the company has forged a number of deals with other companies that has provided significant opportunity for growth, he said. The company extended its 2015 developmental agreement with MedImmune (AZN) for HPV-related cancers. Most recently, on June 1, Inovio and Genentech (RHHBY) announced a collaboration to develop a treatment for bladder cancer. The companies will evaluate a combination of Tecentriq, a PD-1 inhibitor, with Inovio’s NO-5401, a T-cell activating immunotherapy encoding multiple antigens, and INO-9012, an immune activator encoding IL-12.

In addition to collaborating with Genentech, Inovio and Regeneron (REGN) partnered in May on a brain cancer study. Like the Genentech study, Inovio will pair two of its investigative products, INO-5401 T cell-activating immunotherapy encoding multiple antigens and the aforementioned INO-9012, with Regeneron’s PD-1 inhibitor, REGN2810. The Phase Ib/IIa study will evaluate the safety and efficacy of the combination treatment for glioblastoma multiforme, which Kim called “the most devastating form” of brain cancer.

But one of the most intriguing deals Inovio struck this past year provides a toehold in the cancer market in China, as well as a possible entrance into Korea. In February, Inovio and China-based ApolloBio began collaborating to develop VGX-3100 for HPV-related cancers.

Not only is Inovio working on cancer treatments, the company is also using its DNA-sequencing to develop vaccines for infectious diseases, such as Ebola and MERS (Middle East Respiratory Syndrome). Inovio is also putting together a vaccine for the mosquito-borne Zika virus. Phase I results from that trial were positive and Kim said the company is already looking to initiate another vaccine trial in Puerto Rico to assess efficacy and safety data.

“We’ll be looking at how well this vaccine can prevent Zika and by this time next year, we should see how well it prevents the Zika virus,” Kim said.

Lastly, Inovio is also forging ahead with a treatment for HIV. In May, Inovio reported that its vaccine candidate, PENNVAX-GP, generated “amongst the highest overall levels of immune response rates (cellular and humoral) ever demonstrated in a human study by an HIV vaccine.” PENNVAX-GP, which is made of a combination of four HIV antigens, is designed to cover multiple global HIV strains and generate both an antibody (humoral) immune response as well as a T cell (cellular) immune response to both potentially prevent and treat HIV, according to Inovio data. Kim said the program is well funded and he believes there is great potential for this vaccine to go into a larger Phase II efficacy trial in the near future.

Kim said the past year has been a busy one for Inovio and the company has been focused on moving its pipeline forward. Doing so though meant the company had to hire quickly. Over the past year, the company has grown by about 100 employees and with the new deals struck this year, Kim said there is potential to see the same growth rate over the course of the next 12 months.

“Our story isn’t over yet,” Kim said.

He hinted that there are more deals in the works for Inovio, which will continue to carry the company forward.
“We have multiple shots on goal. Few companies can look back one year and see so much advancement and so many accomplishments. Inovio has done that and we continue to perform,” Kim said.